The U.S. organ transplant system approved a new national policy on Nov. 6 for normothermic regional perfusion, a controversial procedure used to remove organs after care is withdrawn.
The new guidelines, which go into effect Dec. 6, establish uniform procedures for normothermic regional perfusion, known as NRP. The Health Resources & Services Administration oversees the system, with normothermic regional perfusion designed to protect potential donors. More than 109,000 Americans are currently waiting for an organ transplant.
About 12 people die every day because of a chronic organ shortage, according to federal figures. The procedure involves attaching an external pump to a donor minutes after circulation ends to restore blood flow to the heart, lungs, kidneys, and liver.
“The hope with NRP is that it increases the supply of organs and it increases the quality of the organs,” Dr. Raymond Lynch, the director of transplantation at the Health Resources & Services Administration, told WYSO.
NRP May Violate the Dead Donor Rule
To perform the procedure, doctors restart circulation after declaring a patient dead following the withdrawal of life support. Critics argue this practice violates the Dead Donor Rule, which dictates that surgeons can only take organs after brain death or circulatory death.
“In order to be dead by circulatory criteria it means we’re not going to attempt to reestablish circulation. But that’s exactly what they do in NRP,” Dr. Lainie Friedman Ross, a University of Rochester bioethicist, told WYSO. “So, yes, I have a real problem with NRP. I think it violates the dead donor rule. It’s taking organs from people who are no longer dead.”
Surgeons typically clamp blood vessels supplying the head to ensure the donor remains brain dead during the procedure. However, retrieval teams reported instances where blood flow returned to the brain.
“We have seen signs of life in NRP when the brain has been reperfused,” Dr. Claire Morgan, a transplant surgeon who serves on the transplant network’s Patient Affairs Committee, told WYSO. “It’s extremely disturbing.”
Additional Venting Requirements
Those reported cases prompted the agency to instruct the Organ Procurement & Transplantation Network to investigate. The newly approved guidelines require surgeons to cut holes in blood vessels above the clamps as an extra safeguard.
“Clamping the blood vessels should stop blood flowing to the brain,” Lynch told WYSO. “Cutting or venting above the level of the clamping is a second safeguard to make sure that if the clamping is insufficient that it immediately drains out of the head and is not supplying warm oxygenated blood to the brain.”
The policy also advises against administering paralyzing drugs that could mask physical movements. Despite these additions, critics maintain that the measures do not resolve fundamental ethical questions.
“I honestly don’t believe they have created a policy that creates much or any more protection than these donors already had,” Morgan told WYSO.
Unresolved Ethical Concerns
Bioethicists argue that implementing the policy before resolving debates over the definition of death moves too quickly. Critics contend the guidelines validate a contested practice without public input prior to the emergency implementation of the first phase.
“I really think the policy is the cart before the horse,” Dr. Matthew DeCamp, a University of Colorado bioethicist, told WYSO. “The fundamental issues around NRP still remain unresolved.”
Proponents maintain that the framework provides necessary safety parameters while addressing urgent medical needs. Officials emphasize that patient and family safety remains central to the expansion of the practice.
“This is an important first step to make sure NRP care is available but that the safety of the family’s loved one is always at the forefront,” Lynch told WYSO. “This is life-saving care that will extend the supply and improve the quality of organs that patients can get in transplant. And if it is done properly, it is safe.”
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